Contaminated vials of the cancer drug Avastin have been linked to an outbreak of eye infections in Florida and Tennessee, which has left some patients blinded.
The FDA issued an infection alert on August 30, indicating that at least 12 reports of eye infections from Avastin have been traced back to repackaged products sold at a Walgreens pharmacy in Hollywood, Florida.
The Tennessee Valley Healthcare System has also reported an additional four patients who also suffered infections after being treated by repackaged Avastin prepared at a VA hospital in Nashville.
The Avastin was repackaged specifically to treat patients suffering from wet age-related macular degeneration (AMD), which is an “off-label” use for the cancer drug.
According to the FDA’s report, patients have contracted Streptococcus endophthalmitis infections after receiving Avastin treatments for AMD. Some of the patients, who already suffered from poor eyesight, completely lost vision in eyes that received Avastin injections.
The infection spread to the brain of one Tennessee man, Lloyd Mason Sylvis, 77, who suffered permanent blindness and brain damage. He is now in a vegetative state and his family has filed a $4 million medical malpractice lawsuit against the Department of Veteran Affairs.
Another Avastin eye infection lawsuit has been filed by Antonio Salgado, 79, of Miami. Salgado received an Avastin eye injection on July 8 and claims to have suffered tremendous pain and had a white film develop over his eye after the injection. Four other patients have also filed lawsuits. Among the defendants named in the complaints are a compounding pharmacy called Infupharma, which divided the Avastin into small 1 mL doses for use to treat AMD.
Avastin (bevacizumab) was approved by the FDA in 2004 for treatment of non-small cell lung cancer and colorectal cancer when combined with chemotherapy. It was developed by Genentech, which was later acquired by Roche. The drug works by restricting blood flow to tumors; starving them. Avastin sales reached nearly $6 billion in 2009.
Avastin is not approved by the FDA to treat wet age-related macular degeneration (AMD), but a recent government-sponsored study found that it was about as effective as Lucentis; which is designed to treat the condition. The major difference between the two is that Avastin is $50 per shot, while Lucentis, distributed by Roche and Novartis, is about $2,000 per shot.
An Avastin eye injection study published earlier this year by Johns Hopkins University researchers found that patients given Avastin to treat AMD were 11% more likely to die and 57% more likely to suffer a stroke than those treated with Lucentis.
AMD affects more than 2 million Americans over the age of 50 and is the leading cause of blindness in the United States, according to the American Academy of Ophthalmology. That number is expected to double by 2020 as members of the “baby boomer” generation continue to age.